Hop Botanical Dietary Supplements - Metabolism and Safety in Women

Food-Drug Interactions Clinical Trial

Official title:

Hop Botanical Dietary Supplements - Metabolism and Safety in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848430
• Other study ID #: 2015-0651
• Status: Completed
• Phase: N/A
• Start date: August 15, 2016
• Est. completion date: September 24, 2019

Study information

• Verified date: August 2020
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Human safety studies were carried out to test whether hop botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs. To test this, a hop dietary supplement (previously tested in women at the University of Illinois at Chicago without any harmful effects) was given with four selected FDA-approved drugs to determine if the hop supplement can increase or decrease how these medications are absorbed, metabolized and excreted by the human body. Preclinical studies had predicted that the hop supplement might affect the metabolism or break down of these probe drugs.

Description:

At the start of a study, subjects were administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples were drawn and analyzed for the concentration of each drug over time. Afterwards, participants consumed the hop dietary supplement twice daily for 14 days to allow for potential inhibition or induction of drug metabolizing enzymes and transporters. Thereafter, the same drugs were taken again to obtain a second measure of drug concentrations in blood over time. Changes in the concentration-time curve values for each probe drug obtained before and after ingestion of the supplement would indicate that metabolism of the probe drugs is impacted by the hop dietary supplement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 24, 2019
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 79 Years

Eligibility

Inclusion Criteria:

• healthy peri- and post-menopausal women ages 40 - 79

• non-smokers

• no-significant medical conditions as assessed by subject-reported medical history, physical examination and blood and urine chemistry screens

• no medical condition that requires chronic use of medication

Exclusion Criteria:

• known allergies or hypersensitivity to caffeine, dextromethorphan, sulfonylureas (tolbutamide), benzodiazepines, red clover, licorice, or hops

• positive pregnancy test

• use of hormone therapy within 8 weeks of study initiation for oral agents, 4 weeks for transdermal or other topical agents

• use of caffeine products 7 days before study participation or during the study

• use of citrus products 7 days before study participation or during the study

• use of other prescription (with the exception of the Mirena® IUD) or non-prescription medicines within the 2 weeks prior to study initiation or during the study

• chronic diseases, such as inflammatory bowel disease, that could alter the absorption or metabolism of the probe substrates

• unwillingness to comply with study requirements

• current participation in another clinical trial

• CYP2D6 deficiency based on phenotyping at screening

• smoker

• hops intake (whether as a botanical dietary supplement or beer) within the previous two weeks and during the study

• use of any dietary supplements within the last 2 weeks prior to study initiation and during the study

• obesity (defined as >33 BMI)

• alcohol or drug abuse

• chronic diseases such as inflammatory bowel disease or diabetes

Related Conditions & MeSH terms

• Food-Drug Interactions

Intervention

Dietary Supplement:
• Humulus lupulus
Extract of spent hops standardized to xanthohumol, isoxanthohumol, 6-prenylnaringenin, and 8-prenylnaringenin

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (2)

van Breemen RB, Chen L, Tonsing-Carter A, Banuvar S, Barengolts E, Viana M, Chen SN, Pauli GF, Bolton JL. Pharmacokinetic Interactions of a Hop Dietary Supplement with Drug Metabolism in Perimenopausal and Postmenopausal Women. J Agric Food Chem. 2020 May — View Citation

van Breemen RB, Yuan Y, Banuvar S, Shulman LP, Qiu X, Alvarenga RF, Chen SN, Dietz BM, Bolton JL, Pauli GF, Krause E, Viana M, Nikolic D. Pharmacokinetics of prenylated hop phenols in women following oral administration of a standardized extract of hops. Mol Nutr Food Res. 2014 Oct;58(10):1962-9. doi: 10.1002/mnfr.201400245. Epub 2014 Sep 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC)	Concentration of probe drugs from blood draws during the 14-day intervention were used to calculate area under the (extrapolated) concentration-time curve to determine any changes compared to pre-intervention.	baseline and 14 days
Secondary	Apparent Clearance	Concentration of probe drugs from blood draws during the 14-day intervention were used to calculate area under the (extrapolated) concentration-time curve to determine any changes compared to pre-intervention.	baseline and 14 days
Secondary	Peak Concentration	Concentration of probe drugs from blood draws during the 14-day intervention were used to calculate peak concentration of probe drug to determine any changes compared to pre-intervention.	baseline and 14 days
Secondary	Time for Peak Concentration	Concentration of probe drugs from blood draws during the 14-day intervention were used to calculate time for peak concentration of probe drug to determine any changes compared to pre-intervention.	baseline and 14 days
Secondary	Drug Half-life	Concentration of probe drugs from blood draws during the 14-day intervention were used to calculate half-life of probe drug to determine any changes compared to pre-intervention.	baseline and 14 days

External Links

•   University of Illinois at Chicago / National Institutes of Health Center for Botanical Dietary Supplements